The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia

Abstract

BackgroundOutpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of “real-world” patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual.MethodsThis study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12.ResultsA total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort.ConclusionDescriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes.Trial registrationClinical Trial Registry: NCT01181960. Registered 12 August 2010.Electronic supplementary materialThe online version of this article (10.1186/s12888-018-1594-1) contains supplementary material, which is available to authorized users.

Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

“…A strength of the current study is that the completion rate of 95.4% is one of the highest observed for a 1-year real-world study in schizophrenia. 38–41 This supports the overall effectiveness and tolerability of PP3M, although it may also be reflective of the requirement for patients to be stabilized prior to inclusion in this study. The high completion rate is consistent with the extremely high proportion of both patients (82%) and physicians (94%) who were satisfied with PP3M treatment at the end of the study.…”

Real-World Evidence of the Clinical and Economic Impact of Long-Acting Injectable Versus Oral Antipsychotics Among Patients with Schizophrenia in the United States: A Systematic Review and Meta-Analysis

“…Most included studies used a study design that adjusted for differences between study cohorts, which limits the risk of bias due to confounding. Three studies did not report a method of multivariable adjustment, including two retrospective cohort studies [ 50 , 52 ] and one pragmatic trial [ 53 ]. These studies reported on the likelihood of being hospitalized [ 50 , 53 ], the likelihood of having an ER visit [ 53 ], and adherence [ 52 ].…”

“…Three studies did not report a method of multivariable adjustment, including two retrospective cohort studies [ 50 , 52 ] and one pragmatic trial [ 53 ]. These studies reported on the likelihood of being hospitalized [ 50 , 53 ], the likelihood of having an ER visit [ 53 ], and adherence [ 52 ]. In all cases, the studies’ point estimates fell within the range of the other studies reporting on these outcomes, and therefore it is unlikely that descriptive studies that did not adjust for confounding materially impacted this review’s conclusions.…”

The effect of long‐acting injectable antipsychotic medications compared with oral antipsychotic medications among people with schizophrenia: A systematic review and meta‐analysis

“…The mean size for all included studies was 4338.1067, and range of studies sizes were 22 to 70 969. These studies included 16 randomized controlled trials (Alphs et al 2016;Bai et al 2007; Barnett et al 2012;Bartzokis et al 2012;Bozzatello et al 2019;Buckley et al 2015;Detke et al 2014;Green et al 2015;Keks et al 2007;Leatherman et al 2014;Macfadden et al 2010;Malla et al 2016;Rosenheck et al 2011;Subotnik et al 2015;Weiden et al 2009Weiden et al , 2012, 11 prospective cohort studies (Aykut 2019;Bellido et al 2008;Conley et al 2003;Devito et al 1978;Joshi et al 2018b;Kim et al 2008;Moore et al 1998;Olivares et al 2009;San et al 2013;Schreiner et al 2014;Tavcar et al 2000), and 48 retrospective cohort studies (Anderson et al 2017;Ascher-Svanum et al 2013;Barrio et al 2013;Baser et al 2015;Bitter et al 2013;Chan et al 2015;Emsley et al 2008;Fan et al 2018;Foster et al 2017;Greene et al 2018;Grimaldi-Bensouda et al 2012;Haro et al 2007;…”

“…Of these, five studies(Barrio et al 2013;Joshi et al 2018b;Leatherman et al 2014;Levitan et al 2016;Petri c et al 2019) reported improvements in PSP scores among LAI as compared with oral users. However, four studies(Bozzatello et al 2019;Joshi et al 2018b;Leatherman et al 2014;Rosenheck et al 2011) reported no differences in LAI and oral users as observed on the PSP scale. In pooled analysis of four studies(Barrio et al 2013;Bozzatello et al 2019;Petri c et al 2019;Rosenheck et al 2011), LAIs were no different than orals in improving PSP mean scores (n = 529, 95%CI = À0.162 to 1.335, P = 0.125; s 2 = 0.513, I 2 = 90.9%, Q = 33.136, df = 3, P < 0.001).…”